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SS Innovations Plans FDA Submission for Robotic System

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The latest update is out from SS Innovations International ( (SSII) ).

On May 8, 2025, SS Innovations International announced plans to submit a De Novo Classification Request to the U.S. FDA for its SSi Mantra 3 surgical robotic system in July 2025. Since its launch in June 2024, the SSi Mantra 3 has been installed in 37 hospitals, performing over 750 multispecialty procedures with no device-related complications. The FDA approval could significantly impact the company’s operations by allowing entry into the U.S. market, complementing its existing presence in seven countries and ongoing efforts for European Union CE Mark approval.

More about SS Innovations International

SS Innovations International, Inc. (Nasdaq: SSII) is a developer of innovative surgical robotic technologies aimed at making robotic surgery affordable and accessible globally. The company offers the ‘SSi Mantra’ surgical robotic system and ‘SSi Mudra’ surgical instruments, supporting various surgical procedures, including robotic cardiac surgery. Headquartered in India, SS Innovations is focused on expanding its global presence with its advanced, user-friendly, and cost-effective solutions.

Average Trading Volume: 22,919

Technical Sentiment Signal: Buy

Current Market Cap: $1.98B

See more insights into SSII stock on TipRanks’ Stock Analysis page.

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